Noninvasive spinal stimulation to improve walking in hereditary spastic paraplegia

Noninvasive Spinal Cord Neuromodulation to Enhance Motor Function in Individuals With Hereditary Spastic Paraplegia

This trial will test whether noninvasive transcutaneous spinal cord stimulation can improve walking and reduce muscle stiffness in adults with hereditary spastic paraplegia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT07417943 on ClinicalTrials.gov

What this trial studies

Participants will receive transcutaneous spinal cord stimulation (tSCS) through self-adhesive electrodes placed on the skin over the lower back without any surgery. Treatments are delivered twice weekly for eight weeks, with each session lasting about one hour, followed by an additional eight-week no-stimulation follow-up to track durability of any changes. Researchers will measure walking speed, walking endurance, muscle stiffness, overall disease severity, and explore effects on bladder/bowel function and muscle strength. The intervention is noninvasive and designed to be combined with participants' usual assistive devices and stable medications.

Who should consider this trial

Good fit: Adults with a clinical diagnosis of hereditary spastic paraplegia who can attend twice-weekly visits, have stable spasticity medications for at least four weeks, can walk at least 10 meters or perform required seated tasks, and can provide informed consent in English are ideal candidates.

Not a fit: People with implanted electronic devices (like pacemakers), open skin lesions at electrode sites, severe cardiopulmonary disease, pregnancy, or a diagnosis of primary lateral sclerosis are excluded and would not receive this noninvasive stimulation.

Why it matters

Potential benefit: If successful, the treatment could improve walking speed, endurance, and reduce spasticity, leading to better mobility and daily function.

How similar studies have performed: Small prior studies of transcutaneous spinal cord stimulation in spinal cord injury and spasticity have shown promising improvements in walking and spasticity, but its use specifically in hereditary spastic paraplegia is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available).
* Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment.
* Able to participate in study visits and assessments with or without assistive devices.
* If ambulatory: able to walk at least 10 meters with or without an assistive device.
* If wheelchair user: able to perform seated mobility tasks and transfers required for assessments.
* Capacity to provide informed consent and follow study procedures, with an ability to communicate and understand instructions in English

Exclusion Criteria:

* Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps).
* Severe cardiopulmonary disease that would make participation unsafe.
* Open skin lesions or severe dermatologic conditions at electrode sites.
* Pregnancy or plans to become pregnant during the intervention period.
* Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a recent surgery on legs.
* Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane). People who use wheelchairs or other mobility aids can participate if they can complete the study's mobility assessments in their usual way.
* Cognitive or psychiatric conditions that make it difficult to give informed consent or follow study instructions.
* Diagnosed with Urinary Tract Infection (UTI), either acute or ongoing, before or at the time of study enrollment.
* Diagnosed with epilepsy.
* Participation in another interventional clinical trial that could affect mobility or spasticity during the study.
* A recent change (within the last 4 weeks) in medications or treatments that affect spasticity or movement (for example: baclofen, tizanidine, botulinum toxin injections).
* Expect to start or change treatments for spasticity or mobility during the study period.
* Any condition judged by the investigator to pose excess risk or confound outcomes.

Where this trial is running

Lexington, Kentucky

• University of Kentucky — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Rahul Sachdeva, PhD — University of Kentucky
• Study coordinator: Rahul Sachdeva, PhD

Conditions Hereditary Spastic Paraplegia